Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
A Prospective Cohort Study of Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
Snakebite Envenomation is recognised as a Neglected Tropical Diseases with high lethality in Sub-Saharan Africa. The current syndromic treatment approach is also fraught by supply pipeline constraints and need for cold-chain, thus negatively impacting outcomes in resource limited settings.
Despite the lack of clinical outcome data from studies in humans, after a comprehensive risk-benefit assessment, the World Health Organisation (WHO), in May 2023, recommended the use of Premium-PANAF polyvalent snake antivenom that is lyophilised, and therefore does not require cold-chain conditions. Médecins Sans Frontières (MSF) also updated its treatment protocol with Premium PANAF being standard of care since June 2025 at Abdurafi (Midre Genet) Health Centre in north west Ethiopia.
Real-world effectiveness by means of Phase IV post marketing studies or pharmacovigilance programmes in countries where it has recently been rolled out is not yet available. This prospective observational cohort study, with a capped sample size of 600 patients, would thus provide much needed evidence on the safety and effectiveness of Premium-PANAF in resource limited settings to help inform national and international treatment guidelines.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Amhara
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Ābderafī、Amhara、エチオピア
- 募集
- Abdurafi Health Center
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コンタクト：
- Site Principal Investigator
- 電話番号：+251911210229
- メール：ethiopia-medco@oca.msf.org
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion criteria
- Snakebite envenoming patients who receive Premium-PANAF antivenom
- Patients who have given written informed consent .
Exclusion criteria
- Snakebite envenoming patients who do not receive Premium-PANAF antivenom
- Patients referred from other centres who already received other antivenom treatment
- Patients who are unable or unwilling to give informed consent
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Snakebite Envenomation treated with Premium PANAF
Patients admitted with snakebite envenomation who recieve Premium PANAF antivenom as standard of care and consent for particpation in the study
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Safety (Allergic Reactions)
時間枠：6 hours
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Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system
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6 hours
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Effectiveness (Correction of Coagulopathy)
時間枠：6 hours
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Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
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6 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effectiveness (Number of Vials)
時間枠：14 days
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Number of doses (vials) needed to reverse the envenomation syndrome
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14 days
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Effectiveness (Rescue Treatment)
時間枠：14 days
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Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF
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14 days
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Effectiveness (Mortality)
時間枠：42 days
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Death from any cause within 42 days of treatment with antivenom
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42 days
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Effectiveness (Patient Specific Function Scale)
時間枠：42 days
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Patient-specific Function Scale (PSFS) score
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42 days
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Effectiveness (Major Bleeding)
時間枠：7 days
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Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria)
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7 days
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Effectiveness (Cessation of Bleeding)
時間枠：6 hours
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Proportion of patients with cessation of bleeding
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6 hours
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Effectiveness (Serial 20WBCT)
時間枠：14 days
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Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT
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14 days
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Effectiveness (Blood Transfusion)
時間枠：14 days
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Proportion of patients who require blood transfusion during hospitalization
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14 days
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Effectiveness (Surgical Intervention)
時間枠：14 days
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Proportion of patients who require surgical intervention
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14 days
|
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Effectiveness (Skin Necrosis)
時間枠：48 hours
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Mean and median total surface area of full thickness skin necrosis in cm2
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48 hours
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Effectiveness (Swelling Reduction)
時間枠：6 hours
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Reduction of swelling extension
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6 hours
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Effectiveness (Renal Replacement Therapy)
時間枠：14 days
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Proportion of participants referred for renal replacement therapy
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14 days
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Effectiveness (Creatine Kinase)
時間枠：14 days
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Peak serum creatine kinase in U/L
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14 days
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Effectiveness (Need for Ventilation)
時間枠：48 hours
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Proportion of participants needing mechanical or manual ventilation
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48 hours
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Safety (Presence of Shock)
時間枠：3 hours
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Proportion of patients with shock (shock defined as systolic blood pressure <90mmHg in adults, or age adjusted blood pressure in children)
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3 hours
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Safety (Need for Adrenaline)
時間枠：14 days
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Proportion of patients requiring adrenaline
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14 days
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Safety (Anaphylaxis)
時間枠：2 hours
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Proportion of patients experiencing anaphylaxis after antivenom administration
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2 hours
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Safety (Need for intravenous fluids)
時間枠：2 hours
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Proportion of patients requiring IV fluids following an allergic reaction
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2 hours
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Safey (Serum Sickness)
時間枠：28 days
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Proportion of patients with confirmed or probable serum sickness
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28 days
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Safety (Any Other)
時間枠：7 days
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Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered
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7 days
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ID2452-Remit-OCA024-07
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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